Non-invasive respiratory assistance system comprising a medical device for maintaining the permeability of the airways

Abstract

The invention relates to a non-invasive respiratory assistance system (10) comprising, at the top, a respiratory mask (11) anatomically shaped to cover at least the nose of the face of a patient, said mask (11) comprising a front face (13) and a through-channel (14), which is intended to be hermetically connected to an artificial ventilation apparatus, and a medical device (1) for maintaining the permeability of the airways, comprising a longitudinal guide (2); gripping means (3) and a member (4) comprising a spatula; said system (10) comprising means for fixing and locking said device (1) inserted within the mouth of said patient; said device (1) being mounted to pass through between said mask (11) and said fixing and locking means, said gripping means (3) and said control means (5) being located toward the front face (13) of said mask (11).

Description

[0001] NON-INVASIVE RESPIRATORY SUPPORT SYSTEM INCLUDING A MEDICAL DEVICE FOR MAINTAINING AIRWAY PATENTIABILITY

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The present invention falls within the medical field of respiratory assistance and artificial ventilation, in particular during general anesthesia.

[0004] As is well known, during the medical care and treatment of a patient, in the event of distress or respiratory failure, but also during a surgical intervention requiring general anesthesia or anesthesia of the anatomical parts that condition the proper functioning of the respiratory tract, it is necessary to provide respiratory assistance to the said patient. This respiratory assistance makes it possible to simulate the biological function of respiration and to ensure gas exchange, for the entire duration when the functioning of the respiratory tract is no longer ensured naturally.

[0005] Further, respiratory assistance can be provided invasively, for example by intubation or by performing a tracheotomy, bringing air directly into the patient's trachea through a tube.

[0006] Respiratory assistance can also be performed non-invasively, by applying a respiratory mask covering the patient's face and ensuring artificial ventilation only through the orifices and cavities of the upper airways (the mouth and nose).

[0007] In addition, respiratory assistance can be carried out manually, generally by first aiders and medical personnel during an emergency intervention, commonly using a valved bag mask or "BAVU" (for "Self-Filling Balloon with One-Way Valve") type resuscitator.

[0008] During planned surgery, respiratory support is usually provided mechanically, by connecting a dedicated device, such as an artificial respirator or assisted mechanical ventilation, to the tube or mask.

[0009] The invention specifically relates to non-invasive respiratory assistance, such as a respiratory mask.

[0010] That said, maintaining airway patency and ensuring respiratory function at the required level is one of the fundamental tasks during a medical procedure, especially during anesthesia. Indeed, trauma or unconsciousness causes a decrease or loss of muscle tone, which can lead to airway obstruction, through blockage of the laryngeal entrance by the epiglottis and the root of the tongue.

[0011] It is therefore necessary to clear the airways and keep them clear. The invention also relates to a medical device for maintaining the patency of the airways, intended to be preferably combined with a non-invasive respiratory assistance system, such as a respiratory mask.

[0012] STATE OF THE ART

[0013] Many existing devices attempt to solve this problem. We know the intubation probe, which has major drawbacks, such as traumatic and complex implantation for the intubation probe tube.

[0014] We also know the laryngeal mask, which is likely to move or be poorly positioned, causing harmful air leaks.

[0015] In addition, such devices usually include a tube connecting them to the ventilation device, which makes it less physiological and natural for the patient, or even traumatic.

[0016] An example of a device for maintaining airway patency is described in document US5024218. Such a device comprises a longitudinal guide with a curved end, intended to be introduced into the oral cavity of a patient and shaped to press against the base of the tongue, as well as an opposite external end provided with gripping means. In addition, the opposite end comprises a spacer located above said guide, in order to act as a support against the jaw of the patient and keep the mouth open. In addition, the guide has projections on the upper face, for guiding medical instruments, such as a tube or a probe to be introduced into the larynx.

[0017] STATEMENT OF THE INVENTION

[0018] The invention aims to overcome the drawbacks of the state of the art by proposing a respiratory assistance system in the form of a mask combined with a medical device for maintaining the patency of the respiratory tract, without a tube and acting on the cavities naturally used for breathing. In particular, said device is limited to acting on the root of the tongue and the associated epiglottis, avoiding the reflexogenic zones of the trachea and the larynx, which facilitates its implantation and extraction, reducing the risks of trauma.

[0019] In short, the device allows the tongue to be held out, to clear the airways and ensure the patient's breathing. Thus, the invention allows non-invasive ventilation during anesthesia and non-traumatic tracheal intubation.

[0020] In addition, the assistance system includes elements to allow the device to be positioned and maintained, facilitating this operation and the stages of anesthesia for the patient.

[0021] To this end, the invention relates to a non-invasive respiratory assistance system, such as a respiratory mask. Such a system is specifically dedicated to the medical device for maintaining the patency of the respiratory tract.

[0022] According to the invention, such a system comprises: - above, a respiratory mask, anatomically shaped to cover at least the nose of a patient's face, said mask comprising a front face and a through channel, intended to be hermetically connected with an artificial ventilation device;

[0023] - a medical device for maintaining the patency of the respiratory tract comprising:

[0024] - at least one longitudinal guide extending along a curved path;

[0025] - gripping means connected to a proximal end of said longitudinal guide;

[0026] - at least one member mounted at a distal end of said longitudinal guide, said member comprising a spatula shaped complementary to the lingual anatomy, said member being movable in displacement relative to said longitudinal guide from a retracted position to a deployed position, and vice versa, i) in the retracted position, the spatula of said member extends along said trajectory of said longitudinal guide; ii) in the deployed position, said member extends inferiorly in projection relative to said longitudinal guide; said medical device further comprising mounted at said proximal end, means for controlling the displacement of said member between the retracted and deployed positions.

[0027] The system includes:

[0028] - means for fixing and locking said device when inserted into the mouth of said patient;

[0029] - said device being mounted through between said mask and said fixing and locking means, said gripping means and said control means being located on the side of the front face of said mask.

[0030] According to additional, non-limiting characteristics, said blocking and fixing means comprise an interdental spacer, anatomically shaped to bear inferiorly and / or superiorly against the patient's teeth, with an upper part and a lower part, said interdental spacer being crossed by said medical device, between said organ and said gripping means.

[0031] According to one embodiment, the interdental spacer comprises an internal part intended to be inflatable, intended to hold said medical device within the patient's mouth.

[0032] According to one embodiment, the interdental spacer comprises an internal part provided to be inflatable, intended to hold said medical device within the patient's mouth. According to one embodiment, the interdental spacer comprises a latch mounted vertically movable at a support connected to said spacer by a sheath, said latch cooperating with notches provided within said at least one guide.

[0033] According to one embodiment, said respiratory mask comprises a removable section, cooperating in a frontally interlocking manner on said mask covering the nose of the patient's face.

[0034] Preferably, said removable section comprises said through channel.

[0035] According to one embodiment, said at least one longitudinal guide of said medical device comprises at least one channel for insertion and extraction of medical instruments.

[0036] According to one embodiment, one of the medical instruments comprises the gripping means and extends longitudinally within said at least one channel, so as to move said organ between the retracted position and the deployed position.

[0037] According to one embodiment, said organ is crossed by a guide channel of at least one of the medical instruments, the inlet of said guide channel being located in alignment with an outlet of said at least one channel.

[0038] PRESENTATION OF THE DRAWINGS

[0039] Other characteristics and advantages of the invention will emerge from the detailed description which follows of the non-limiting embodiments of the invention, with reference to the appended figures, in which:

[0040] Figure 1 schematically represents a front perspective view of an embodiment of a respiratory assistance system, with blocking means in the form of an interdental spacer, ensuring the fixing of a medical device for maintaining the permeability of the respiratory tract, in the retracted position;

[0041] Figure 2 schematically represents a perspective side view of an embodiment of said medical device, in the retracted position, cooperating with fixing and blocking means in the form of an interdental spacer;

[0042] Figure 3 schematically represents a side view of an embodiment of the medical device alone in the retracted position;

[0043] Figure 4 schematically represents a view similar to Figure 3, showing said medical device in the deployed position, as well as the direction of sliding actuation of the control means relative to the gripping means for the passage from the retracted position to said deployed position;

[0044] Figure 5 schematically represents a view along a vertical section of the implementation of the medical device introduced in a retracted position into the patient's oral cavity;

[0045] Figure 6 schematically represents a view similar to Figure 5, showing the medical device tilted into the deployed position, coming to bear to maintain the base of the tongue; Figure 7 schematically represents a profile view of another embodiment of the medical device, in the deployed position and equipped with a longitudinal guide forming a channel for insertion and extraction of medical devices;

[0046] Figure 8 schematically represents a perspective view of the rear face of an embodiment of the longitudinal guide of the medical device, with four channels of different diameters;

[0047] Figure 9 schematically represents two views along a vertical section of the implementation of the medical device introduced into the patient's oral cavity, in a retracted position and in a deployed position, showing in particular the joint movement of the rear end of the guide channel with the movement of the organ;

[0048] Figure 10 schematically represents an exploded view of another embodiment of the system, showing in particular an inflatable interdental spacer and highlighting in transparency, on the one hand, an internal channel provided along said spacer allowing the medical device to be inserted therein by sliding and, on the other hand, an internal channel along a guide of said medical device, allowing an instrument, such as a probe or a camera, to be inserted therein by sliding;

[0049] Figure 11 schematically represents a double view of an embodiment of an interdental spacer with an upper part in a deflated configuration on the left and in an inflated configuration on the right;

[0050] Figure 12 schematically represents a front view of an embodiment of the medical device, showing in particular the organ in the deployed position, under a sliding action of an instrument along a guide in the form of a tube;

[0051] Figure 13 schematically represents a view of an embodiment, showing in particular the member in the deployed position and a tube passing through the guide and said member, with an orientation following said member;

[0052] Figure 14 schematically represents a simplified view of an embodiment of the respiratory assistance system, showing in particular tips for closing the guide channels; and

[0053] Figure 15 represents an enlarged view of Figure 14, showing in particular the plate forming the latch intended to cooperate with slots provided on the guide, as well as the fixing by fitting of the mask onto the interdental spacer.

[0054] DETAILED DESCRIPTION

[0055] The present invention relates to respiratory assistance and artificial ventilation, in particular during general anesthesia. To this end, the invention relates to a medical device 1 for maintaining the patency of the respiratory tract, hereinafter referred to as "device 1", as well as a respiratory assistance system 10, hereinafter referred to as "system 10", equipped with such a device 1. Firstly, the device 1 is provided for releasing circulation along the respiratory tract and maintaining this circulation, by pressing against the base or root of the tongue to press it forward, namely towards the frontal or anterior anatomical part of the patient's skull).

[0056] To do this, the device 1 comprises at least one longitudinal guide 2. According to the embodiment visible in the figures, the device 1 comprises two guides 2 extending parallel and spaced apart from each other.

[0057] Each guide 2 can have any shape and section, preferably a flattened shape, like a blade, with one or more segments, allowing it to be easily inserted when placed in the oral cavity.

[0058] Furthermore, the length of the guide 2 is sufficient to allow the insertion of its distal end 20 until it penetrates into the throat of a patient, close to the root of the patient's tongue, while maintaining a proximal end 21 outside the mouth. Preferably, the length of the guide 2 is greater than the length of the oral cavity of an adult patient, allowing its insertion up to the root of the tongue, but also to adapt the portion of the guide 2 introduced into the oral cavity according to the size of the latter.

[0059] Thus, guide 2 serves partly to stiffen the part intended to be introduced into the mouth, as well as to support other elements.

[0060] In addition, said guide 2 extends along a curved path, namely it has a downward inflection from the proximal end 21 to the distal end 20. Such an inflection gives a concave shape below the guide 2, making it possible to adapt to the oral morphology, in particular to match the shape of the curve of the tongue. This curved path can be given by an arched and rounded shape of the guide 2, or by angles between its segments.

[0061] Further, the device 1 comprises gripping means 3 connected to the proximal end 21 of said longitudinal guide 2. Such gripping means 3 may be of any shape and are adapted to allow the device 1 to be held and manipulated by a practitioner.

[0062] According to one embodiment, visible in the figures, the gripping means 3 comprise a handle forming a hollow female part. This female part can be of any shape, preferably in the form of a half-tube, open towards the front. The rear wall of the handle then serves as a surface on which the practitioner's fingers can be positioned to grip and hold the device 1. In addition, the proximal end 21 can be positioned between two fingers, when gripping the device 1, ensuring that it is firmly held in the hand.

[0063] According to the embodiments visible in the figures, said handle extends orthogonally or essentially orthogonally relative to said curved trajectory of said guide 2 at its proximal end 21. Thus, when the guide 2 is positioned horizontally or essentially horizontally inside the oral cavity, then the handle extends vertically or essentially vertically.

[0064] According to different embodiments, visible in figures 1 to 6, said handle extends symmetrically or substantially symmetrically on either side of the guide 2. According to another embodiment, as visible in figures 7 to 9, the handle extends under the guide 2.

[0065] Furthermore, the device 1 comprises at least one member 4 mounted at the distal end 20 of said longitudinal guide 2. In addition, said member 4 comprises a spatula shaped to complement the lingual anatomy.

[0066] In particular, said spatula has a flat, rounded and curved shape, concave at the bottom. In addition, the edges of said spatula are rounded, to avoid any risk of injury during insertion and extraction, as well as during the use of said device 1.

[0067] Advantageously, the device 1 provides for pressing on the base of the tongue, in order to press it forward, keeping the airways open.

[0068] To do this, said member 4 is movable in displacement relative to said longitudinal guide 2 from a retracted position to a deployed position, and vice versa.

[0069] In the retracted position, the spatula of said member 4 extends along said trajectory of said longitudinal guide 2. In other words, said spatula extends in the extension of the guide 2, allowing the insertion and extraction of the device 1 within the oral cavity, until said spatula reaches the base of the tongue. Such a retracted position in insertion of the device 1 within an oral cavity is highlighted in Figure 5.

[0070] In the deployed position, said member 4 extends downwardly projecting relative to said longitudinal guide 2. In other words, the member 4 forms an angle relative to said trajectory at the distal end 20, so as to press on the base of the tongue. Such a deployed position of the member 4 for pushing back the tongue by pressing on its base is highlighted in Figure 6.

[0071] Furthermore, the transition from one position to another, as well as the maintenance in the deployed position of the organ 4, is ensured by the practitioner holding the gripping means 3.

[0072] To do this, said medical device 1 also comprises, mounted at said proximal end 21, means 5 for controlling the movement of said member 4 between the retracted and deployed positions.

[0073] According to the corresponding embodiment, the control means 5 may be in the form of a male part shaped complementary and intended to cooperate within said female part of the gripping means 3, in the deployed position of said member 4. In particular, in the case of a semi-tubular female part, the male part has a cylindrical shape, preferably a half-cylinder shape with the wall of revolution on the side of the hollow of said female part. The dimensions of the male and female parts are complementary, namely that the external dimensions of the male part correspond to the clearance to the internal dimensions of the female part, in particular the diameter of the male part is equivalent to the clearance to the internal diameter of the female part. Such a complementary configuration is notably visible in Figures 3 and 4.

[0074] Thus, the male part of the control means 5 can be inserted into the female part of the gripping means 3 during actuation to move the member 4 from the retracted position to the deployed position, and can be extracted therefrom during the movement from the deployed position to the retracted position (or vice versa). In short, the movement of the control means 5 closer to or away from the gripping means 3 makes it possible to actuate the member 4 between its deployed and retracted positions. Figure 4 shows in particular a movement of the control means 5 closer to the gripping means 3, actuating the deployment of the member 4 from the retracted position to the deployed position.

[0075] According to corresponding embodiments, the male part is aligned with the female part, symmetrically or substantially symmetrically with respect to the rod 50 (Le. with respect to the guide 2), or else said male part extends under said rod 50.

[0076] According to one embodiment, one and / or the other of the male and / or female parts can be provided removable, relative to the rod 50 and / or said guide 2, allowing them to be removed once the device 1 is in place. This removable nature also makes it easier to clean these parts.

[0077] According to another embodiment, as notably visible in Figure 10, the male and female parts may comprise locking means, notably by clipping. For this purpose, the male part may be equipped with a step which cooperates in fitting with a portion of the female part, preferably the lower edge of the female part. Thus, this locking makes it possible to maintain the male and female parts between them in the deployed position of the member 4.

[0078] Concerning the mobility of the spatula, according to one embodiment, said member 4 is mounted as an extension of said distal end 20 of said longitudinal guide 2. In addition, said member 4 is pivotally articulated between the retracted and deployed positions. In other words, the member 4 rotates around the distal end 20, downwards to reach the deployed position, and conversely upwards to return to the retracted position. For example, the transition to the deployed position can be carried out by a clockwise rotation, while the return to the retracted position is carried out by a counterclockwise rotation.

[0079] Figure 4 highlights the clockwise direction of rotation towards the deployed position of said member 4.

[0080] According to one embodiment, the member 4 is mounted in rotation through first rings 6, secured to a front end of the spatula, at the junction with the guide 2. These first rings 6 are secured to the distal end 20 of the guide 2. In particular, a pair of first rings 6 is secured to each distal end 20 of the two guides 2.

[0081] Each first ring 6 can be free to rotate with said guide 2 and fixed on the member 4, or vice versa.

[0082] According to other embodiments, the member 4 may be provided with an axis or a shaft mounted in rotation on the distal end 20 of the guide(s) 2.

[0083] According to yet another embodiment, the member 4 can be mounted on the distal end 20 through an elastic articulation, in particular made of a material allowing it to be bent or flexed relative to the guide 2, such as for example natural or synthetic rubber.

[0084] According to a preferred embodiment, the actuation of the member 4 is carried out through a mechanical connection similar to a cam, namely that a translation confers the rotational movement of the member 4.

[0085] To do this, according to one embodiment, as visible in the figures, said control means 5 comprise at least one rod 50 connected at one end in rotation with said member 4.

[0086] According to another equivalent embodiment, said at least one rod 50 may be in the form of a rigid or semi-rigid, or even flexible, connection, such as for example in the form of a cable. In this case, the control means 5 may operate, alone or in combination with the gripping means 3, like a bicycle brake handle.

[0087] According to one embodiment, the member 4 is mounted in rotation through second rings 7, secured to a front end of the spatula, at the junction with the rod 50. These second rings 7, in particular in the form of a pair, are secured to the rear end of the rod 50.

[0088] Each second ring 7 can be free to rotate with the rod 50 and fixed on the member 4, or vice versa.

[0089] According to other embodiments, the member 4 may be provided with an axis or a shaft mounted in rotation on the rear end of the rod 50.

[0090] In addition, said rod 50 is slidably mounted relative to the longitudinal guide 2. According to the corresponding embodiment, the rod 50 is slidably mounted within the spacing between the two guides 2. In other words, the rod 50 moves in translation relative to the guide 2, in particular relative to the two guides 2 which frame it, serving as longitudinal guidance.

[0091] Preferably, the rod 50 slides along the guide(s) 2, via a sliding connection. According to one embodiment, like the guide 2, the rod 50 may have a flattened shape, with one or more segments, as well as a curvature or inflections parallel to or along said trajectory.

[0092] According to another embodiment, said rod 50 is part of said guide 2, in telescopic form, allowing elongation for the activation of the member 4 towards the deployed position (or towards the retracted position), or vice versa during its shrinking (or reciprocally towards the deployed position).

[0093] Further on, the sliding of said rod 50 relative to said longitudinal guide 2 ensures, in one direction, a tilting of said member 4 from the retracted position to the deployed position. In particular, the translational movement from the front to the rear of the device 1 (i.e. from the frontal or anterior anatomical part of the skull to the posterior part), actuates the rotation of said member 4 to the deployed position, namely during a push on the control means 5.

[0094] In a reverse direction, the sliding of the rod 50 ensures the return of said member 4 from the deployed position to the retracted position. In particular, the translational movement from the rear to the front, actuates the rotation of said member 4 towards the retracted position, namely through traction on the control means 5.

[0095] In short, preferably, the tilting of said member 4 is controlled in the direction extending in translation from the proximal end 21 towards the distal end 20, in approach of the control means 5 relative to said gripping means 3. Such a movement is highlighted by the positions visible in Figures 4 and 5.

[0096] According to the corresponding embodiment, said gripping means 3 comprise a handle forming a hollow female part. In addition, said handle is crossed by said rod 50, in particular through an opening provided through the wall of said handle.

[0097] As said control means 5 comprise a male part mounted at the opposite end of said rod 50.

[0098] Furthermore, as mentioned previously, said male part is shaped complementary and intended to cooperate within said female part in the deployed position of said member 4.

[0099] Thus, the rod 50 secured to the male part slides freely within the opening of the female part when the control means 5 are brought together and separated from the gripping means 3.

[0100] According to an alternative embodiment, the control means 5 may comprise a manual actuator, in the form of a trigger or the like, ensuring control of the transition from the retracted position to the deployed position.

[0101] It will be noted that the return to the retracted position can be carried out automatically, through elastic return means, rotating said member 4 around its axis of rotation, or else pushing back or bringing the control means 5 closer to the gripping means 3.

[0102] Furthermore, the holding in the deployed position can be locked by any type of means, in particular by snap-fastening the control means 5 with the gripping means 3, by clipping, by means of a one-way interlocking, for example with teeth and indentations, or in the form of a latch, or by means of an adhesive connecting said means 3, 5 together. Unlocking can be carried out by any type of corresponding means, in particular through a push button, unlocking the snap-fastening or clipping of said means 3, 5.

[0103] In particular, in the corresponding embodiment, the locking and unlocking take place between the male and female parts.

[0104] Furthermore, locking and unlocking are carried out on the part of the device 1 located on the outside, allowing easy access for the practitioner.

[0105] Thus, the gripping means 3, alone or combined with the control means 5, fulfill the function of setting the member 4 in motion. In particular, it is the handle of the gripping means 3 which can be connected to the proximal end 21, to control the change of position of the member 4 located at the distal end 20.

[0106] In a related manner, the device 1 and its components may be made of any type of material, preferably compatible with medical use, such as surgical steel, a composite material and / or a plastic-based material. In particular, the guide(s) 2 and the rod 50, as well as the gripping means 3 and the control means 5 may be made of plastic material, in particular by molding.

[0107] According to one embodiment, the device 1 is provided to facilitate the insertion and extraction of medical instruments 8.

[0108] Such medical instruments 8 may be, in a non-limiting manner, an endotracheal tube, an endoscopic camera system, one or more measuring sensors, in particular temperature sensors, or even collection or sampling systems, in particular for performing a biopsy.

[0109] To do this, the guide 2 may comprise at least one channel 22, extending superiorly and serving for the longitudinal guidance of the instruments 8, along said guide 2.

[0110] According to a preferred embodiment, as visible in Figures 7 and 8, said at least one longitudinal guide 2 comprises at least one channel 22 for inserting and extracting medical instruments 8. Such a channel 22 then gives a longitudinal hollow beam shape to said guide 2, serving as a conductor and allowing medical instruments 8 to slide along this beam, without risking touching the walls of the patient's oral cavity.

[0111] By way of example, figure 13 shows an instrument 8 of the probe tube type introduced along a channel 22 within the longitudinal guide 2, said probe tube being oriented downwards during its passage through the member 4 in the deployed position, in particular through a rounded tubular portion equipping said member 4 at the level of a portion located on the side of said guide 2.

[0112] According to a corresponding embodiment, said member 4 is crossed by a guide channel of at least one of the medical instruments 8, the inlet of said guide channel being located in alignment with an outlet of said at least one channel 22.

[0113] In particular, the member 4 is crossed by a single guide channel aligned at the outlet of the median channel 22 of the guide 2, so that in the deployed position of the member 4, this guide channel forms a rounded angle, ensuring the penetration of an instrument 8 downwards and the distal end of said member 4, during the insertion and sliding of said instrument 8 along the channel 22 of the guide 2.

[0114] In particular, the guide 2 comprises several collinear channels 22, in particular at least three or four channels 22, with identical or different internal diameters, allowing the passage of medical instruments 8 with corresponding circumferences. In particular, a wider channel 22, preferably median, allows the passage of an endotracheal tube or preferably the tube for the intubation of such an endotracheal tube, while channels of smaller diameters allow the passage of instruments 8, such as probes or endoscopes. In this way, after installation of the device 1, the endotracheal tube can be inserted into the trachea in a simple and reliable manner, through its already correctly positioned tube.

[0115] Opening on the front face, each of the channels 22 allows the practitioner to easily and quickly insert and extract the medical instruments 8, without having to worry about managing their trajectory, through the guidance along each of said channels 22 of the guide 2.

[0116] Further, said at least one channel 22 can be closed at its external end. To do this, the device 1 comprises shutters 220, sized complementary to the dimensions of the corresponding channel 22. These shutters 220 are provided removable, so as to close each of the channels 22 which is not used for the insertion or extraction of a medical instrument. These shutters 220, in the closed position, ensure a sealed or hermetic closure of the corresponding channels 22, in particular through the material constituting them, such as for example an elastic material, such as a composite or a synthetic rubber.

[0117] Furthermore, said at least one insertion and extraction channel 22 extends to a rear end 23 secured to said member 4.

[0118] According to one embodiment, said insertion and extraction channel 22 comprises a flexible rear end 23.

[0119] According to another embodiment, the rear end 23 of said insertion and extraction channel 22 is provided to be articulated. Thus, the rear end 23 of the channel 22 can follow the movements of the member 4, as can be seen in particular in the views of FIG. 9.

[0120] Furthermore, according to one embodiment, the rear end 23 has an inclined or slanted outlet orifice 24, with a slope inclined forward from the member 4 upwards. The outlet orifice 24 may optionally be slightly flared. This particular shape ensures easier guidance of the medical instruments 8 at the outlet, in particular during their extraction.

[0121] Therefore, the possibility of inserting an endoscopic camera system, with a correct and safe installation, separate from other medical instruments, offers the advantage of monitoring the presence of unwanted contents in the oropharyngeal cavity, or even considering the passage of a probe with an aspirator to eliminate unwanted contents.

[0122] This monitoring allows the insertion of an endotracheal tube to be checked, guaranteeing its perfect insertion at any time during the operation.

[0123] Furthermore, the use of device 1 allows to solve problems related to difficult and complex intubations, for example in the case of complex anatomy of the respiratory tract. The use of device 1 ensures the insertion of the endotracheal tube exactly up to the entrance of the larynx, while guaranteeing ventilation via the mask 1 1 and, consequently, oxygenation immediately after the installation of device 1 , even before any possible tracheal intubation. There is then no time limit for the insertion of the endotracheal tube into the trachea, facilitating the task of the practitioner during this manipulation and reducing the related stress.

[0124] According to a corresponding embodiment, the gripping means 3 can be attached to one of the medical instruments 8 to be introduced into said at least one channel 22, preferably at the distal end of an endotracheal tube or an endoscopic camera. Thus, when inserting the instrument 8, its sliding along said at least one channel 22 inwards causes the member 4 to tilt towards the deployed position. Conversely, when withdrawing said instrument 8, the member 4 returns to the retracted position.

[0125] In a related manner, the insertion of an instrument 8 such as an endoscopic camera makes it possible to directly visualize the correct positioning of the device 1, in particular the tilting of said member 4 towards the deployed position so that it comes to be correctly positioned in support against the base or the root of the tongue in order to press it forward.

[0126] Thus, the device 1, with its elongated and flattened shape, allows it to be easily inserted into the oral cavity of a patient. The practitioner grips it from outside the mouth, securely, with a good grip, simply allowing the deployment of the organ 4, in order to push the tongue back to its base and ensure good maintenance of the patency of the airways. In addition, once in place and deployed, the device 1 allows the practitioner to implant related medical instruments 8, in particular to perform intubation if necessary and pass a tube, a catheter or even a probe. The device 1 can then serve as a guide for the introduction of these instruments 8, in particular along said guide 2 and the rod 50.

[0127] The invention also relates to a respiratory assistance system 10.

[0128] Such a system 10 is intended to be non-invasive, namely that it allows artificial ventilation to be provided without intubation or penetration of a medical instrument beyond the oral cavity, using only the circulation occurring naturally from the lungs through the oral cavity and the nasal cavity.

[0129] To do this, the system 10 is of the respiratory mask type and therefore comprises, above, a respiratory mask 11. Such a mask 11 is anatomically shaped to cover at least the nose of a patient's face.

[0130] In particular, the mask 1 1 has an overall shell shape. Such a shell can be made of any type of material, suitable for the medical field, such as a plastic or composite material.

[0131] The shell shape of said mask 11 allows the rim to rest above the upper lip and on the bridge of the nose, as well as on the cheeks, encompassing this part of the patient's face. Said mask 11 may have dimensions allowing it to cover, depending on its configuration, the cheekbones and the sides of the lower jaw area, or only the nose area.

[0132] Furthermore, the mask can be held in position on the patient's head by dedicated means, such as an adjustable strap or at least an elastic band, surrounding the skull, or passing behind the ears, ensuring sufficient tension to apply the mask 1 1 tightly against the patient's skin.

[0133] According to one embodiment, the circumference of the mask 11 may comprise a peripheral seal 12, made of flexible and / or elastic material, ensuring a sealed contact by pressing said mask 11 against the skin of the face. In particular, such a seal 12 may be made of a composite material, in particular silicone, ensuring an adherent or sticky contact with the skin.

[0134] According to one embodiment, the edge of said mask 11 can be secured and held in place on the patient's face by means of adhesive, projecting laterally around the edge of said mask 11, from the peripheral seal(s) 12.

[0135] Alternatively or additionally, other means of attachment may be considered to ensure the positioning and maintenance of the mask 1 1 on the patient's face, in a hermetic manner.

[0136] Further, said mask 11 comprises a front face 13 and a through channel 14, intended to be hermetically connected with an artificial ventilation device. It will be noted that such an artificial ventilation device can be included in the system 10. This device can be of any type, in particular a dedicated electrical device, such as a mechanical or assisted ventilation device, or even a manually operated bag. The artificial ventilation device is connected to the mask 11 by tubes or ribbed tubing provided for this purpose, mounted in a sealed fit with said channel 14.

[0137] In addition, the mask 11 also comprises a rear face 130, located opposite the front face 13. This rear face 130 is therefore located on the side of the patient's face.

[0138] According to one embodiment, the system provides that said respiratory mask 11 comprises a section 111 provided to be removable, cooperating in a frontally interlocking manner on said mask 11 covering the nose of the patient's face. Such a removable section 111 can therefore be positioned and removed from the mask 11, making it easier to place said mask 11 on the patient's face.

[0139] Furthermore, the fitting of the section 1 1 1 on the mask 1 1 is intended to be airtight.

[0140] Thus, the mask 1 1 can be positioned and adjusted on the patient's face before the start of anesthesia, without rushing. Then, the removable section 1 1 1 can be positioned to close the mask 1 1 , in particular after the patient has started to be anesthetized, that is to say only when mechanical ventilation takes over from natural ventilation. Such a configuration of the mask 1 1 makes it possible to create a high concentration of oxygen inhaled by the patient.

[0141] According to one embodiment, said removable section 111 comprises said through channel 14.

[0142] According to one embodiment, in particular when the through channel 14 opens into the removable part 111, the latter comprises an air filter, making it possible to eliminate pathogenic agents and bacteria, reducing the need to intervene at the level of the filter of the artificial ventilation device.

[0143] Advantageously, the system 10 comprises a medical device 1 for maintaining the permeability of the respiratory tract according to one and / or other of the embodiments described previously.

[0144] In addition, the system 10 comprises means for fixing and locking said device 1 when inserted into the mouth of said patient.

[0145] Furthermore, in order to be able to easily manipulate the device 1 and actuate the member 4 between the retracted and deployed positions, said device 1 is mounted passing through between said mask 11 and said fixing and locking means. In addition, said gripping means 3 and said control means 5 are located on the side of the front face 13 of said mask 11.

[0146] According to one embodiment, said mask 11 may comprise orifices passing through its lower wall and opening towards the rear of the housing. These orifices may in particular be two in number located opposite the nasal orifices. Said orifices allow communication between the mouth and the nose, like an anastomosis.

[0147] According to one embodiment, these orifices can open onto the front face 13 of the mask 11 and can be connected to a gas supply source, in particular a dioxygen (O2) supply source. Such a supply source can comprise a tip or cannula, secured to the front face 13 of said mask 11. Thus, the tip or cannula of the supply source can be connected to a dioxygen supply network, in particular through a catheter.

[0148] According to the corresponding embodiment, when closing the mask 11, the fitting of the removable section 111 closes the orifices, in particular in a sealed manner, blocking the supply of oxygen.

[0149] According to one embodiment, said locking and fixing means comprise an interdental spacer 17. Such an interdental spacer 17 is anatomically shaped to bear inferiorly and / or superiorly against the patient's teeth.

[0150] According to one embodiment, as visible in Figure 10, said interdental spacer 17 can be connected, at an external portion, lower to said mask 11. This connection can be provided articulated and removable, in particular by clipping an axis within complementary jaws provided projecting in the lower part of said mask 11.

[0151] According to another embodiment, the clipping of the mask 11 with the interdental spacer 17 can be carried out through complementary lugs and cavities, cooperating in interlocking, in particular by plastic and elastic deformation of the materials.

[0152] Such a configuration is notably visible in figures 14 and 15.

[0153] According to one embodiment, the interdental spacer 17 comprises an internal part 173 provided to be inflatable, intended to hold said medical device 1 within the patient's mouth.

[0154] It will be noted that the inflation and deflation of this internal part 173 is carried out by suitable means, for example with a manually operated pump, connected through said mask 11, in particular by a channel or a cannula connected to said internal part.

[0155] Thus, once the mask 11 is in place, before or after the medical device 1 is introduced into the patient's mouth, the inflation of the internal part 173 of the interdental spacer 17 makes it possible to block and maintain the system 10 within the patient's oral cavity, while adapting to its morphology. In addition, this inflation of the internal part 173 makes it possible to improve the seal provided at the oral cavity by the system 10. According to one embodiment, said interdental spacer 17 comprises a tube 177 for circulating gas, such as oxygen, connecting each end, namely passing through said interdental spacer 17 to an outlet end 178 internal to said interdental spacer 17.

[0156] According to one embodiment, said interdental spacer 17 comprises an upper part 170 and a lower part 171, connected to each other. By slightly opening the parts 170, 171, it is then possible to move the interdental spacer 17 along the device 1, to adapt to the individual morphological characteristics and anatomy of each patient.

[0157] According to one embodiment, the upper part 170 of the interdental spacer 17 is mounted integrally and projecting from the rear face 130 of said mask 11. This upper part 170, integral and static with respect to the mask 11, therefore makes it easy to position it in the patient's mouth.

[0158] According to a corresponding embodiment, the upper part 170 or the lower part 171 of the interdental spacer 17 is provided to be inflatable, or both. Preferably, only the lower part 171 is provided to be inflatable.

[0159] Figure 11 shows an exemplary embodiment of such an interdental spacer 17 with an inflatable internal part 173, showing said internal part 173 deflated on the left and inflated on the right.

[0160] Thus, the mask 11 is positioned with the upper part 170 against the upper jaw of the patient, who only has to close the mouth to bring the parts 170, 171 of said interdental spacer 17 together, ensuring sufficient pinching to hold the mask 11, while allowing the passage of the device 1 between said parts 170, 171.

[0161] In addition, according to one embodiment, said parts 170, 171 comprise at least one chute 172 for receiving the teeth of said patient. In particular, as visible in FIG. 2, each chute 172 has a hollow arcuate shape, complementary in size to internally receive the patient's teeth.

[0162] According to a preferred embodiment, each chute 172 comprises a material having elastic characteristics, in particular flexibility, or even shape memory, preferably temporary. In particular, the bottom of one and / or the other of the chutes 172 of one and / or the other of the parts 171, 172 is covered with said elastic material. Such a material makes it possible to come to bear on the teeth and ensure the blocking of the interdental spacer 17.

[0163] Alternatively, it is the interdental spacer 17 which is entirely made of a flexible and / or elastic material, preferably with shape memory, such as a plastic or composite gel.

[0164] Furthermore, such an interdental spacer 17 can be made of any type of material, suitable for the medical and dental field, preferably made of composite material or plastic-based, or even natural or synthetic rubber. In particular, said interdental spacer 17 can be made by molding the patient's teeth or by a dental impression, ensuring its proper implantation and maintenance in the mouth.

[0165] In addition, said interdental spacer 17 is crossed by said medical device 1, between said organ 4 and said gripping means 3.

[0166] According to the corresponding embodiment, the interdental spacer 17 is crossed by the guide(s) 2 and the rod 50.

[0167] Furthermore, the interdental spacer 17 can be mounted to slide along the guide(s) 2 and the rod 50, making it possible to adjust the length of introduction of said device 1 into the patient's mouth.

[0168] Therefore, it is by closing the patient's mouth that the interdental spacer 17 pinches the device 1, in particular the rod 50, blocking it in the deployed position of said member 4.

[0169] It should be noted that locking the mouth in the closed position can be achieved by any means, including using a chin strap or a tie, or even an adhesive.

[0170] Thus, the device 1 is blocked and held by the interdental spacer 17, simply by closing the patient's mouth, so that his teeth bite said interdental spacer 17, thus pinching said device 1 to hold it in place. This configuration is all the more suitable for the treatment of patients with a mouth morphology adapted to the insertion of said interdental spacer 17, in particular for adults.

[0171] According to one embodiment, said fixing and locking means comprise at least one plate 18 mounted in translation along said longitudinal guide 2. In addition, said guide 2 is provided with notches 19 providing indexed positions for fixing said plate 18. In other words, the notches 1 are positioned and spaced along the guide(s) 2, making it possible to place said plate 18 more or less far away, adapting the length of the part of the device 1 introduced into the mouth, so that the member 4 is positioned as best as possible against the tongue, as close as possible to its base.

[0172] According to a preferred embodiment, the notches 19 are in the form of bars, positioned projecting or hollow from the upper face of the guide(s) 2, in particular connecting the two guides 2 together.

[0173] According to another embodiment, the notches 19 are arranged in the form of slots on the surface of the guide(s) 2, preferably at the level of its upper face. These notches 19 in the form of slots are intended to cooperate with the plate 18 forming a latch mounted to move vertically relative to the guide 2, and therefore to the notches 19, from a raised position to a lowered position. In the raised position of the latch, the guide(s) 2 are free to slide, while in the lowered position, the lower edge of the latch is inserted and fits into a corresponding slot, which blocks the translation of the guide(s) 2.

[0174] Such notches 19 in the form of slots cooperating with the latch are notably visible in figure 12.

[0175] According to one embodiment, the plate 18 forming a latch is fitted by clipping projecting lugs into corresponding grooves. In particular, the lugs are arranged to project relative to the walls of the plate 18 and the grooves are arranged in a hollow within an insertion slot of said plate 18, said slot being arranged to pass through the thickness of said interdental spacer 17, until it opens internally, in particular within the sheath 174.

[0176] Such a configuration is particularly visible in Figure 15.

[0177] According to a preferred embodiment, said fixing and blocking means also comprise a labial support 10 mounted freely in translation along said longitudinal guide 2, between said plate 18 and said member 4.

[0178] According to another embodiment, as visible in figure 1 , the support 190 can be mounted integral with the interdental spacer 17, on the opposite side relative to the internal part 173, in particular in the case where it is intended to be inflatable.

[0179] The internal part 173 is then connected to the support 190 by a sheath 174, dimensioned additionally in order to allow the insertion and sliding of the guide(s) 2. In short, the guide 2 can slide freely, from an inlet orifice 175 provided through the support 190 along the sheath 174 until it opens out at the level of the internal part 173, through an outlet orifice 176.

[0180] Furthermore, the support 190 can then serve as a stop for the gripping means 3, when maneuvering all or part of the medical device 1 and / or the instruments 8 introduced therein.

[0181] In the corresponding embodiment, the latch can be mounted to move vertically relative to the support 190, namely that it slides vertically within its thickness, as visible in FIG. 14.

[0182] Such a 190 lip support may have any shape, including a circular or ovoid shape.

[0183] Said lip support 190 can be made of any type of material, preferably flexible and / or elastic, such as a composite or plastic-based material, or even natural or synthetic rubber. This elastic characteristic allows the lip support 190 to slide along the guide(s) 2 and come to bear against the lips. In addition, the elastic material can ensure the locking of the rod 50 relative to the guide 2.

[0184] In addition, said plate 18 comes to bear against an external face of said lip support 190, during adjustment according to one of said indexed positions. In other words, when putting the device 1 in place, it is introduced into the patient's mouth and the passage from the retracted position to the deployed position of the member 4 is activated. Then, after closing the mouth, the lip support 190 is moved so that its internal face comes to bear against the patient's lips. The plate 18 is then positioned against the external face of said lip support 190, according to a position indexed by the corresponding notch 19. This notch 19 then blocks the plate 18 against the lip support 190, which adheres hermetically to the patient's lips, in particular by deforming locally due to its elastic material.

[0185] Thus, between the plate 18 and the member 4 in the deployed position, the device 1 is engaged in the patient's mouth, enclosed by the lips and the base of the tongue, thus ensuring its support.

[0186] According to a corresponding embodiment, when said at least one longitudinal guide 2 of said medical device 1 comprises at least one channel 22 for inserting and extracting medical instruments 8, preferably several, then for each of said at least one insertion and extraction channel 22, an orifice is provided facing said plate 18, as well as possibly said labial support 190. In other words, said plate 18, once in place to hold the device 1 in its deployed position of the organ 4, it is possible to introduce and extract the medical instruments 8 via the orifices in alignment with the channels 22.

[0187] Such an embodiment may or may not be combined with one and / or the other of the embodiments provided with said interdental spacer 17.

[0188] It will be noted that once the system 10 is in place, the mouth can be sealed by related means, such as an adhesive applied to the lips by pinching or sealing using a medical plaster.

[0189] As an example of use of the respiratory assistance system 10, in the context of general anesthesia, once the mask 11 is positioned on the patient's face and connected to the mechanical ventilation device by channel 14, pre-oxygenation is carried out for one to three minutes. The mask 1 can then be fixed, through the elastic tie or adhesives.

[0190] The patient is then placed under anesthesia. Since the installation of device 1 is a relatively painless procedure and moderately irritates the reflexogenic zones, a superficial level of anesthesia can be used without the use of narcotic analgesics at this stage, which in most cases preserves natural breathing and significantly reduces the risk of developing hypoxia or hypercapnia.

[0191] Having reached a level of anesthesia which suppresses consciousness, nausea and swallowing reflexes, ensuring sufficient relaxation of the muscles of the oropharynx, the patient's mouth is opened to introduce the device 1, with the organ 4 in the retracted position. The spatula is placed behind the tongue, similar to the introduction of an anesthesiological laryngoscope. Once in place, the control means 5 are actuated in close proximity to the gripping means 3, generating the tilting of the organ 4, which presses against the root of the tongue and the epiglottis, in the position of opening the respiratory tract.

[0192] The device 1 is then blocked and fixed, according to the elements corresponding to the aforementioned embodiments. If necessary, the mouth is made airtight.

[0193] Full respiratory support is then provided and it is possible to deepen the anesthesia, use inhalation anesthetics and administer muscle relaxants.

[0194] Additionally, before placing the patient under anesthesia, once the 1 1 mask is in place, the oxygen supply can be provided, in particular at a suitable respiratory concentration. The oxygen supplied from the source comes out through the orifices, in particular in the form of a curtain when the orifices form a row. As mentioned previously, when positioning the removable 1 1 1 section, this supply is then closed by blocking the orifices.

[0195] In the hands of an experienced operator, such a procedure of implantation of the device 1 and the system 10 lasts a few seconds, which, combined with probably preserved spontaneous breathing, significantly reduces the risk of developing hypoxia and hypercapnia.

[0196] Thus, the respiratory assistance system 10, combined with fixation and blocking of the device 1 for maintaining the patency of the respiratory tract, ensures implantation without risk of damaging the mucous membranes or internal walls, without trauma. Once in place, the device 1 is blocked, without risk of untimely displacement, in particular if the patient must be moved or transported. This system 10 and its device 1 can be used during emergency interventions, as well as for medical operations requiring anesthesia. Finally, the system 10 offers natural ventilation, using the respiratory tract, without resorting to intubation. Furthermore, an advantage of the system 10 and the device 1 lies in a faster adaptation and medical recovery of the patient to completely independent breathing, once the anesthesia is over.

[0197] Furthermore, the device 1, coupled or not to the system 10, makes it possible to modify current anesthesia techniques, in particular requiring tracheal intubation, as is the case in a large number of surgeries, in particular major abdominal surgeries, including for esophageal and gastric interventions, in particular for the treatment of obesity.

[0198] In particular, it is possible to perform and maintain intubation during anesthesia and part of the surgery, then to proceed with extubation immediately after the end of the main stage of the surgery, then to apply respiratory assistance almost simultaneously, through the mask 11 of the respiratory assistance ventilation system 10. Such a procedure makes it possible to limit the tracheal intubation time, thereby facilitating the return to spontaneous breathing of the patient.

Claims

CLAIMS 1. Non-invasive respiratory assistance system (10), of the respiratory mask type, comprising: - above, a respiratory mask (11), anatomically shaped to cover at least the nose of a patient's face, said mask (11) comprising a front face (13) and a through channel (14), intended to be hermetically connected with an artificial ventilation device; - a medical device (1) for maintaining the patency of the respiratory tract comprising: - at least one longitudinal guide (2) extending along a curved path; - gripping means (3) connected to a proximal end (21) of said longitudinal guide (2); - at least one member (4) mounted at a distal end (20) of said longitudinal guide (2), said member (4) comprising a spatula shaped complementary to the lingual anatomy, said member (4) being movable in displacement relative to said longitudinal guide (2) from a retracted position to a deployed position, and vice versa, i) in the retracted position, the spatula of said member (4) extends along said trajectory of said longitudinal guide (2); ii) in the deployed position, said member (4) extends inferiorly in projection relative to said longitudinal guide (2); said medical device (1) further comprising mounted at said proximal end, means (5) for controlling the displacement of said member (4) between the retracted and deployed positions; characterized in that said system (10) comprises: - means for fixing and locking said device (1) when inserted into the mouth of said patient; - said device (1) being mounted through between said mask (11) and said fixing and blocking means, said gripping means (3) and said control means (5) being located on the side of the front face (13) of said mask (11).

2. System (10) according to the preceding claim, characterized in that - said blocking and fixing means comprise an interdental spacer (17), anatomically shaped to bear inferiorly and / or superiorly against the patient's teeth, with an upper part (170) and a lower part (171), said interdental spacer (17) being crossed by said medical device (1), between said organ (4) and said gripping means (3).

3. System (10) according to the preceding claim, characterized in that - the interdental spacer (17) comprises an internal part intended to be inflatable, intended to hold said medical device (1) within the patient's mouth.

4. System (10) according to one of claims 2 or 3, characterized in that - the interdental spacer (17) comprises a latch mounted vertically movable at the level of a support (190) connected to said spacer (17) by a sheath (174), said latch cooperating with notches (1) provided within said at least one guide (2).

5. System (10) according to any one of the preceding claims, characterized in that - said respiratory mask (11) comprises a removable section (111), cooperating in a frontally interlocking manner on said mask (11) covering the nose of the patient's face.

6. System (10) according to the preceding claim, characterized in that - said removable section (1 1 1 ) comprises said through channel (14).

7. System (10) according to any one of the preceding claims, characterized in that - said at least one longitudinal guide (2) of said medical device (1) comprises at least one channel (22) for inserting and extracting medical instruments (8).

8. System (10) according to the preceding claim, characterized in that - one of the medical instruments (8) comprises the gripping means (3) and extends longitudinally within said at least one channel (22), so as to move said member (4) between the retracted position and the deployed position.

9. System (10) according to any one of claims 7 or 8, characterized in that - said member (4) is crossed by a guide channel of at least one of the medical instruments (8), the entrance to said guide channel being located in alignment with an exit of said at least one channel (22).

Images